Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboUnknown status

Studying the antidepressant effects of intravenous ketamine in patients with major depressive disorder

Randomised controlled trial (n=30) assessing IV ketamine 0.5 mg/kg (2 weekly infusions) versus IV scopolamine 4 µg/kg and saline placebo as add-on treatment in patients with major depressive disorder.

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Target Enrollment
30 participants
Study Type
Phase II/III interventional
Design
Randomized

Detailed Description

Randomised, interventional Phase II/III study of intravenous ketamine 0.5 mg/kg given once weekly for two weeks as an adjunctive treatment in patients with major depressive disorder on stable oral antidepressants.

Comparators include intravenous scopolamine 4 µg/kg (weekly for two weeks) and saline placebo; outcomes include change in MADRS and CGI at baseline, day 1 and day 3 after each infusion, and weekly up to 6 weeks.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

IV ketamine

experimental

Intravenous ketamine 0.5 mg/kg given once weekly for two weeks as add-on to antidepressant therapy.

Interventions

  • Ketamine0.5 mg/kg
    via IV• weekly• 2 doses total

    Infusion given once per week for 2 weeks (2 sessions).

IV scopolamine

active comparator

Intravenous scopolamine 4 µg/kg given once weekly for two weeks as active comparator.

Interventions

  • Compound4 mcg/kg
    via IV• weekly• 2 doses total

    Scopolamine 4 µg/kg infusion once per week for 2 weeks.

Saline placebo

inactive

Intravenous saline placebo infusion.

Interventions

  • Placebo
    via IV• weekly• 1 doses total

    Saline placebo infusion once; comparator/placebo arm.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Major depressive episode according to DSM-IV-TR
  • Montgomery-Asberg Depression Rating Scale score of at least 20
  • On stable doses of oral antidepressant medication
  • Ability to provide informed consent

Exclusion Criteria

  • Any unstable medical condition or clinically relevant abnormality likely to compromise study conduct, evaluation or safety
  • Schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, eating disorder, substance-related disorders
  • Drug allergy to ketamine or scopolamine
  • Use of adjunct medications for depression and tricyclic antidepressants
  • Pregnant or breast-feeding women
  • Inability to follow procedures in the study protocol for any reason

Study Protocol, Arms & Participants

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Study Details

Locations

Unknown facility — Australia

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